Label: PLEO POLY D- lactococcus lactis immunoserum rabbit, streptococcus pyogenes immunoserum rabbit, streptococcus viridans group immunoserum rabbit, staphylococcus epidermidis immunoserum rabbit, staphylococcus aureus immunoserum rabbit, streptococcus pneumoniae immunoserum rabbit and mycobacterium bovis immunoserum rabbit solution/ drops

  • NDC Code(s): 60681-2802-1
  • Packager: Sanum Kehlbeck GmbH & Co. KG
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/10

If you are a consumer or patient please visit this version.

  • PURPOSE

    Homeopathic Medicine

    0.34 fl oz
    (10 mL)

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  • Indications

    for minor external skin infections.

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  • DOSAGE

    Unless otherwise prescribed, apply 5-10 drops into the bend of the elbow and rub in three times daily.

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  • WARNING

    If symptoms persist more than a few days, contact a licensed practitioner.

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

    Keep this and all other medications out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Protect from light and heat.

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  • INGREDIENTS

    10 mL aqueous dilution contains: antigens 9X of Streptococcus lacticus, -pyogenes, -haemolyticus, -viridans; Staphylococcus albus, -pharyngis, -aureus; Diplococcus lanceolatus; Mycobacterium tuberculosis typus bovinus.

    Inactive Ingredient water

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  • Tamper Evident

    Do not use this product if tamper-evident strip on base of bottle cap is missing or broken.

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  • SPL UNCLASSIFIED SECTION

    Made in Germany

    Distributed by:
    SANUM USA Corp.
    1465 Slater Road
    Ferndale, WA 98248

    Manufactured by:
    Sanum-Kehlbeck
    GmbH & Co. KG
    Hoya, Germany

    Rev. 05/2010

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  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

    Pleo® Poly D DROPS 9X (applied topically)

    Homeopathic Medicine
    Indications: for minor focal external skin infections.
    0.34 fl oz (10 mL)

    Dosage: Unless otherwise prescribed, 5-10 drops into the bend of the elbow and rub in three
    times daily. Warning: If symptoms persist more than a few days, contact a licensed practitioner.
    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care
    professional before using this product. Keep this and all medications out of the reach of
    children.
    In case of accidental overdose, seek professional assistance or contact a Poison
    Control Center immediately. Protect from light and heat. TAMPER EVIDENT: Do not use this
    product if tamper-evident seal on base of bottle cap is missing or broken. INGREDIENTS: 10 mL
    aqueous dilution contains: antigens 9X of Streptococcus lacticus, -pyogenes, -haemolyticus, -
    viridans; Staphylococcus albus, -pharyngis, -aureus; Diplococcus lanceolatus; Mycobacterium
    tuberculosis typus bovinus
    Rev. 05/2010

    Principal Display Panel- 10 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    PLEO POLY D 
    lactococcus lactis immunoserum rabbit, streptococcus pyogenes immunoserum rabbit, streptococcus viridans group immunoserum rabbit, staphylococcus epidermidis immunoserum rabbit, staphylococcus aureus immunoserum rabbit, streptococcus pneumoniae immunoserum rabbit, and mycobacterium bovis immunoserum rabbit solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:60681-2802
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    lactococcus lactis immunoserum rabbit (lactococcus lactis immunoserum rabbit) lactococcus lactis immunoserum rabbit 9 [hp_X]  in 10 mL
    streptococcus pyogenes immunoserum rabbit (streptococcus pyogenes immunoserum rabbit) streptococcus pyogenes immunoserum rabbit 9 [hp_X]  in 10 mL
    streptococcus viridans group immunoserum rabbit (streptococcus viridans group immunoserum rabbit) streptococcus viridans group immunoserum rabbit 9 [hp_X]  in 10 mL
    staphylococcus epidermidis immunoserum rabbit (staphylococcus epidermidis immunoserum rabbit) staphylococcus epidermidis immunoserum rabbit 9 [hp_X]  in 10 mL
    staphylococcus aureus immunoserum rabbit (staphylococcus aureus immunoserum rabbit) staphylococcus aureus immunoserum rabbit 9 [hp_X]  in 10 mL
    streptococcus pneumoniae immunoserum rabbit (streptococcus pneumoniae immunoserum rabbit) streptococcus pneumoniae immunoserum rabbit 9 [hp_X]  in 10 mL
    mycobacterium bovis immunoserum rabbit (mycobacterium bovis immunoserum rabbit) mycobacterium bovis immunoserum rabbit 9 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60681-2802-1 1 in 1 CARTON
    1 10 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 04/07/1999
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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